Sponsor Change for 54 NADAs, 1 ANADA to Zoetis
02/27/2014
FDA Amends Animal Drug Regs to Reflect Withdrawals
02/27/2014
Comments Sought on Rx Drug Ad Info
02/27/2014
OMB OKs Info on Tobacco Prevention Campaign
02/27/2014
Federal Register Notice: FDA’s collection of information entitled “Evaluation of the Food and Drug Administration&rsqu...
Guidance on Fixed-Combination Drug Products
02/24/2014
Comments Sought on Drug Supply Chain Requirements
02/24/2014
Federal Register Notice: FDA is establishing a public docket to receive information and comments on standards for the interoperabl...
Hearing On OTC Drug Review
02/24/2014
Federal Register Notice: FDA will hold a public hearing 3/25-26 to obtain input on the Over-the-Counter (OTC) Drug Review (sometim...
CDER Seeks Firms for Site Tours Program
02/21/2014
Federal Register Notice: CDER is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Intera...
OMB OKs Info on CGMPS, QSRs
02/21/2014
Federal Register Notice: FDA’s collection of information entitled “Current Good Manufacturing Practice (CGMP); Quality...
FDA Withdraws Phenylproponolamine Products
02/20/2014
Federal Register Notice: FDA is withdrawing approval of 13 NDAs and 7 ANDAs for products containing phenylpropanolamine. The produ...